Clinical trials: Pediatric Safety and Effectiveness
Fracture, Lengthening; Leg
Pediatric Orthopaedic Implant Safety & Efficacy
Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity.
- Conditions
- Fracture, Lengthening; Leg, Orthopedic Disorder, Deformity of Limb
- Trial name
- Global POISE (NCT05361980)
- Testing
- Pediatric orthopaedic implant
- Where
- Canada
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Chemotherapy-Induced Nausea and Vomiting
A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting that cancer patients experience after treatment. Aprepitant has been well-studied in adults, but not in children.
- Trial name
- NCT01757210
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- West Virginia University Healthcare
Atopic Dermatitis
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)
This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.
- Trial name
- NCT05032859
- Testing
- tapinarof cream, 1%, vehicle cream
- Where
- 62 sites in United States, Canada
- Volunteers
- 406 people
- Sponsor
- Organon and Co
Duchenne Muscular Dystrophy
A Study to Evaluate Safety, Tolerability, and Efficacy of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) Who Have Completed Study 4658-102 (NCT03218995)
The purpose of this extension study is to evaluate the ongoing safety and tolerability of additional treatment with eteplirsen administered once weekly by intravenous (IV) infusion in male participants with DMD who have…
- Trial name
- NCT03985878
- Testing
- Eteplirsen
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 15 people
- Sponsor
- Sarepta Therapeutics, Inc.
Prolonged Sedation
Dexmedetomidine for Prolonged Sedation in PICUs
Sedation management of the critically ill patients is still a challenge for the pediatric intensivists. Worldwide the most common sedation approach includes the concomitant use of opioids and benzodiazepines.
- Trial name
- PROSDEX (NCT03760978)
- Testing
- Dexmedetomidine
- Where
- 9 sites in Italy
- Volunteers
- 163 people
- Sponsor
- Azienda Ospedaliera di Padova
Nasal Congestion
A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold
The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.
- Trial name
- NCT05365789
- Testing
- Blocked Nose Baby nasal spray, Standard of care
- Where
- Poland
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Church & Dwight Company, Inc.
Acute Kidney Injury
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI).
- Trial name
- SCD-PED-01 (NCT02820350)
- Testing
- SCD-F40
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- CytoPherx, Inc
Crohn's Disease
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
- Trial name
- NCT00409682
- Testing
- Adalimumab
- Where
- 45 sites in United States, Belgium and 6 more
- Volunteers
- 192 people
- Sponsor
- Abbott
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Hereditary Angioedema (HAE)
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of…
- Trial name
- NCT02052141
- Testing
- CINRYZE 500, CINRYZE 1000
- Where
- 8 sites in United States, Germany and 3 more
- Volunteers
- 12 people
- Sponsor
- Shire
Presymptomatic Diabetes Type 1 (Stage 1), Diabetes Mellitus, Type I
Treatment of Presymptomatic (Stage 1) Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody
The main purpose of the study is to check: Can therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or an anti-CD20 antibody preparation (rituximab) be successfully used in children with pre-diabetes to treat or…
- Conditions
- Presymptomatic Diabetes Type 1 (Stage 1), Diabetes Mellitus, Type I, Diabetes Mellitus, Type 1
- Trial name
- PreTreg (NCT06688331)
- Testing
- ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs), Anti-CD20 (rituximab)
- Where
- 9 sites in Poland
- Volunteers
- 150 people
- Sponsor
- PolTREG S.A.
Short Bowel Syndrome
Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support.
- Trial name
- NCT02980666
- Testing
- Teduglutide
- Where
- 5 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Shire
X-Linked Hypophosphatemia
Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).
- Trial name
- NCT02915705
- Testing
- burosumab, Oral Phosphate Supplement, active vitamin D
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin, Inc.
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period
Study ACTIVATE-Kids (AG348-C-023) will evaluate the efficacy and safety of orally administered mitapivat as compared with placebo in pediatric participants with pyruvate kinase deficiency (PKD) who are not regularly receiving…
- Trial name
- ACTIVATE-Kids (NCT05175105)
- Testing
- Mitapivat
- Where
- 19 sites in United States, Canada and 5 more
- Volunteers
- 30 people
- Sponsor
- Agios Pharmaceuticals, Inc.
Growth Hormone Deficiency
A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is
This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children.
- Trial name
- DETECT (NCT04786873)
- Testing
- Macimorelin, Arginine, Clonidine
- Where
- 45 sites in United States, Armenia and 9 more
- Volunteers
- 101 people
- Sponsor
- AEterna Zentaris
Brain Diseases
Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI
The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix Children's Hospital.
- Trial name
- NCT03023566
- Testing
- Dotarem
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Phoenix Children's Hospital
Malignant Solid Tumor - Malignant Nervous System Neoplasm
Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
Primary Objectives: Phase 1 Part: To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid tumors including…
- Trial name
- NCT01751308
- Testing
- Cabazitaxel (XRP6258)
- Where
- 13 sites in United States, Canada
- Volunteers
- 39 people
- Sponsor
- Sanofi
Asthma
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.
- Trial name
- NCT00392288
- Testing
- Ciclesonide
- Where
- 6 sites in United States, Hungary and 4 more
- Volunteers
- 528 people
- Sponsor
- AstraZeneca
Indirect Inguinal Hernia, Pediatric
Comparative Study of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy
This study aims to compare between two techniques to treat hernia in children which are Needlescopic inguinal hernia repair and Open classic surgery as regard operative time, cosmetic appearance, recurrence and other complications
- Trial name
- Needlescopic (NCT06936423)
- Testing
- Open herniotomy, Needlescopic percutaneous Internal ring suturing
- Where
- Egypt
- Volunteers
- 43 people
- Sponsor
- Ain Shams University
Autism, Autistic Disorder
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
The purpose of this study is to determine if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea, constipation, abdominal pain, and bloating, in…
- Conditions
- Autism, Autistic Disorder, Child Development Disorders, Pervasive, Gastrointestinal Diseases
- Trial name
- NCT00110708
- Testing
- Oralgam (human immunoglobulin)
- Where
- 22 sites in United States
- Volunteers
- 120 people
- Sponsor
- PediaMed Pharmaceuticals
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